Today is 2022-08-12

Clinical research for anti-CD7 U-CAR-T bridging HST for CD7+ T/NK hematologic malignances
download

注册号:

Registration number:

ChiCTR1900025311 

最近更新日期:

Date of Last Refreshed on:

2019-09-10 

注册时间:

Date of Registration:

2019-08-22 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

靶向CD7的通用型CAR-T细胞桥接造血干细胞移植治疗难治、复发T/NK细胞血液恶性肿瘤的临床研究 

Public title:

Clinical research for anti-CD7 U-CAR-T bridging HST for CD7+ T/NK hematologic malignances  

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

靶向CD7的通用型CAR-T细胞桥接造血干细胞移植治疗难治、复发T/NK细胞血液恶性肿瘤无对照、多中心的临床研究 

Scientific title:

Clinical research for anti-CD7 U-CAR-T bridging HST for CD7+ T/NK hematologic malignances: a multicenter, uncontrolled trial  

研究课题代号(代码):

Study subject ID:

 

在二级注册机构或其它机构的注册号:

The registration number of the Partner Registry or other register:

 

申请注册联系人:

黄瑞昊 

研究负责人:

张曦 

Applicant:

Ruihao Huang 

Study leader:

Xi Zhang 

申请注册联系人电话:

Applicant telephone:

+86 18984398751 

研究负责人电话:

Study leader's telephone:

+86 13808310064 

申请注册联系人传真 :

Applicant Fax:

 

研究负责人传真:

Study leader's fax:

 

申请注册联系人电子邮件:

Applicant E-mail:

1169731117@qq.com 

研究负责人电子邮件:

Study leader's E-mail:

zhangxxi@sina.com 

申请单位网址(自愿提供):

Applicant website(voluntary supply):

 

研究负责人网址(自愿提供):

Study leader's website(voluntary supply):

 

申请注册联系人通讯地址:

中国重庆市沙坪坝区新桥街道183号 

研究负责人通讯地址:

中国重庆市沙坪坝区新桥街道183号 

Applicant address:

183 Xinqiao Street, Shapingba District, Chongqing, China 

Study leader's address:

183 Xinqiao Street, Shapingba District,Chongqing, China 

申请注册联系人邮政编码:

Applicant postcode:

400037 

研究负责人邮政编码:

Study leader's postcode:

 

申请人所在单位:

陆军军医大学第二附属医院新桥医院血液科 

Applicant's institution:

The Hematology Department of the Second Affiliated Hospital of the Army Medical University  

是否获伦理委员会批准:

是 

Approved by ethic committee:

Yes 

伦理委员会批件文号:

Approved No. of ethic committee:

AF/SC-08/1.0 

伦理委员会批件附件:

Approved file of Ethical Committee:

查看附件View

批准本研究的伦理委员会名称:

陆军军医大学第二附属医院新桥医院医学伦理委员会 

Name of the ethic committee:

the Second Affiliated Hospital of the Army Medical University Medical Ethics Committee 

伦理委员会批准日期:

Date of approved by ethic committee:

2019-08-27 

伦理委员会联系人:

任谦 

Contact Name of the ethic committee:

Ren Qian 

伦理委员会联系地址:

中国重庆市沙坪坝区新桥街道183号 

Contact Address of the ethic committee:

183 Xinqiao Street, Shapingba District, Chongqing, China 

伦理委员会联系人电话:

Contact phone of the ethic committee:

 

伦理委员会联系人邮箱:

Contact email of the ethic committee:

 

研究实施负责(组长)单位:

陆军军医大学第二附属医院血液科 

Primary sponsor:

The Hematology Department of the Second Affiliated Hospital of the Army Medical University  

研究实施负责(组长)单位地址:

中国重庆市沙坪坝区新桥街道183号 

Primary sponsor's address:

183 Xinqiao Street, Shapingba District, Chongqing, China 

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

中国

省(直辖市):

重庆

市(区县):

Country:

China

Province:

Chongqing

City:

单位(医院):

陆军军医大学第二附属医院

具体地址:

沙坪坝区新桥街道183号

Institution
hospital:

The Hematology Department of the Second Affiliated Hospital of the Army Medical University

Address:

183 Xinqiao Street, Shapingba District

经费或物资来源:

陆军军医大学临床重大领域技术创新项目 

Source(s) of funding:

the Foundation of the Innovative Scientific Research of Third Military Medical University (CX2019LC111) 

研究疾病:

难治复发 CD7阳性 T/NK 细胞血液肿瘤 

Target disease:

refractory/relapse CD7+ T/NK cell hematology malignancies 

研究疾病代码:

 

Target disease code:

 

研究类型:

观察性研究 

Study type:

Observational study 

研究所处阶段:

探索性研究/预试验 

Study phase:

研究目的:

阐明通用CART桥接移植在CD7阳性难治复发T/NK血液肿瘤治疗安全性和有效性。 

Objectives of Study:

Clarify the safety and efficiency of UCART bridging HST in treatment of CD7+ T/NK hematology malignancies  

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

单臂 

Study design:

Single arm 

纳入标准:

1. 年龄18-70岁,男女不限; 2. 患有CD7阳性难治/复发T/NK血液肿瘤,无有效的治疗方式供选择的患者; 3. 预计存活期>3月; 4. ECOG≤2分; 5. 满足移植条件。 

Inclusion criteria

1. aged 18 to 70 years, male or female; 2. patients with CD7 positive refractory/relapse T/NK hematologic malignancies, with no effective treatment options; 3. projected survival of > 3 months; 4. ECOG <= 2; 5. transplant conditions are met 

排除标准:

1. 不受控的阳性感染; 2. 前期接受过任何其他细胞免疫治疗; 3. HIV, HBV, HCV阳性。 4. 心脑等重要脏器功能障碍; 

Exclusion criteria:

1. uncontrolled positive infection; 2. prior treatment with any other cellular immunotherapy; 3. of HIV, HBV, HCV positive; 4. dysfunction of heart, brain or other important organs. 

研究实施时间:

Study execute time:

From2019-09-01To 2021-06-30 

征募观察对象时间:

Recruiting time:

From2019-09-20To 2021-03-31 

干预措施:

Interventions:

组别:

1

样本量:

30

Group:

1

Sample size:

干预措施:

回输靶向CD7的通用CART细胞

干预措施代码:

Intervention:

infusion of anti-CD7 UCART cells

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

重庆 

市(区县):

 

Country:

China 

Province:

Chongqing 

City:

 

单位(医院):

陆军军医大学第二附属医院 

单位级别:

三级甲等 

Institution
hospital:

The Second Affiliated Hospital of the Army Medical University  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

重庆 

市(区县):

 

Country:

China 

Province:

Chongqing 

City:

 

单位(医院):

重庆医科大学附二院 

单位级别:

三级甲等 

Institution
hospital:

The Second Affiliated Hospital of Chongqing Medical University  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

贵州 

市(区县):

 

Country:

China 

Province:

Guizhou 

City:

 

单位(医院):

贵州医科大学附属医院 

单位级别:

三级甲等 

Institution
hospital:

The Affiliated Hospital of Guizhou Medical University  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

四川 

市(区县):

 

Country:

China 

Province:

Sichuan 

City:

 

单位(医院):

西部战区总医院 

单位级别:

三级甲等 

Institution
hospital:

The General Hospital of Western Theater Command  

Level of the institution:

Teriary A hospital 

国家:

中国 

省(直辖市):

云南 

市(区县):

 

Country:

China 

Province:

Yunnan 

City:

 

单位(医院):

解放军昆明总医院 

单位级别:

三级甲等 

Institution
hospital:

Kunming General Hospital of the PLA  

Level of the institution:

Teriary A hospital 

国家:

中国 

省(直辖市):

云南 

市(区县):

 

Country:

China 

Province:

Yunnan 

City:

 

单位(医院):

昆明医科大学附一院 

单位级别:

三级甲等 

Institution
hospital:

The First Affiliated Hospital of Kunming Medical University  

Level of the institution:

Teriary A hospital 

国家:

中国 

省(直辖市):

云南 

市(区县):

 

Country:

China 

Province:

Yunnan 

City:

 

单位(医院):

昆明医科大学附二院 

单位级别:

三级甲等 

Institution
hospital:

The Second Affiliated Hospital of Kunming Medical University  

Level of the institution:

Teriary A hospital 

测量指标:

Outcomes:

指标中文名:

3周骨髓原始细胞比例

指标类型:

主要指标 

Outcome:

3 weeks the ratio of bone marrow blast cells

Type:

Primary indicator 

测量时间点:

测量方法:

骨髓穿刺

Measure time point of outcome:

Measure method:

bone marrow puncture

指标中文名:

可测量病灶大小及SUV摄取值

指标类型:

主要指标 

Outcome:

1 month measurable lesion size and SUV uptake value

Type:

Primary indicator 

测量时间点:

测量方法:

PET/CT

Measure time point of outcome:

Measure method:

PET/CT

指标中文名:

三个月总缓解率

指标类型:

次要指标 

Outcome:

three months overall response rate

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

采集人体标本:

Collecting sample(s)
from participants:

标本中文名:

血液

组织:

血液组织

Sample Name:

Blood

Tissue:

Blood tissue

人体标本去向

使用后保存 

说明

Fate of sample:

Preservation after use 

Note:

标本中文名:

骨髓

组织:

髂骨

Sample Name:

bone Marrow

Tissue:

iliac bone

人体标本去向

使用后保存 

说明

Fate of sample:

Preservation after use 

Note:

征募研究对象情况:

Recruiting status:

尚未开始

Not yet recruiting

年龄范围:

Participant age:

最小 Min age 18 years
最大 Max age 70 years

性别:

男女均可

Gender:

Both

随机方法(请说明由何人用什么方法产生随机序列):

无需随机

Randomization Procedure (please state who generates the random number sequence and by what method):

No need for random

盲法:

N/A

Blinding:

N/A

试验完成后的统计结果(上传文件):

Calculated Results ater
the Study Completed(upload file):

是否共享原始数据:

IPD sharing

Yes

共享原始数据的方式(说明:请填入公开原始数据日期和方式,如采用网络平台,需填该网络平台名称和网址):

原始数据于试验结束后6个月以内采用临床试验公共管理平台向公众开放查询, http://www.medresman.org

The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url):

The raw data will open to the public with public management platform in the 6 months after clinical trials finished, http://www.medresman.org

数据采集和管理(说明:数据采集和管理由两部分组成,一为病例记录表(Case Record Form, CRF),二为电子采集和管理系统(Electronic Data Capture, EDC),如ResMan即为一种基于互联网的EDC:

原始数据采用临床试验公共平台进行记录和管理

Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture:

The raw data will record and manage by the public management platform of clinical trials

数据与安全监察委员会:

Data and Safety Monitoring Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2019-08-22
return list